19 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FlexBoardTM, EagleBoardTM, BreastBoard SXTM
FDA 510(k)
FDA Class 2
·Radiology
EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)
FDA 510(k)
FDA Class 2
·Immunology
ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CLARIUS ULTRASOUND SCANNER
FDA Adverse Event
Malfunction
·CLARIUS MOBILE HEALTH CORP.·Product code IYN·October 17, 2024
ALENTI
FDA Adverse Event
Malfunction
·ARJOHUNTLEIGH POLSKA SP. ZO.O.·Product code FSA·October 22, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011
URETEX TO2 URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON) -1018233·Product code OTN·May 6, 2013
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code HSB·July 1, 2014
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code HSB·June 30, 2014
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code HSB·June 30, 2014
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·October 7, 2025
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·May 5, 2026
GLENOID RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·October 15, 2025
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·December 20, 2025
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·October 22, 2025
GLENOID RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PHX·May 26, 2026
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·October 29, 2024
GLENOID RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·April 14, 2026
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023